Project to support full Phase 2 trial, GMP manufacturing scale-up
Seattle, WA, October 6, 2021 – Lumen Bioscience—a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases—today announced new development funding from the US Army for its Covid-19 monoclonal antibody drug cocktail. The support is provided by the US Army Medical Research and Development Command (USAMRDC), operating through the Medical Technology Enterprise Consortium (MTEC).
This announcement builds on a previous Army grant to Lumen that funded preclinical development of LMN-301, an investigational product directed at treating and preventing the gastrointestinal (GI) manifestations of Covid-19. These symptoms are an important aspect of the disease but have received less attention than the respiratory and immunological aspects due to the lack of scalable technologies for treating such infections. Lumen’s spirulina-based GMP manufacturing and delivery technology is uniquely suited for such applications.
“Everyone knows about the respiratory symptoms of Covid-19, but it’s less well appreciated among non-specialists that a majority of patients also endure GI-related issues, which can be quite severe,” said Brian Finrow, Lumen’s co-founder and CEO. “A therapeutic targeting this source of infection could reduce the viral load, inhibit disease progression, and potentially eliminate a significant source of disease transmission. Our unique biologics platform is the first to potentially allow for the cost-effective manufacturing of therapeutic proteins at pandemic scale, so we’re pleased to have this opportunity to contribute to the fight against Covid-19.”
It has been definitely established that the virus infects the GI tract and leading studies show that such symptoms appear in a majority of patients with Covid-19. The Lumen Bio product under development, LMN-301, is a cocktail of antibody-like proteins that bind to the spike protein of SARS-CoV-2 and prevent it from infecting the ACE2-presenting cells that line the GI tract. The contract extension will fully fund a Phase 2 clinical trial among Covid-19 patients. A portion of the funds will also support a significant expansion of Lumen’s existing cGMP manufacturing plant.
Lumen plans to carry out the clinical trial in Brazil in collaboration with the widely respected TOGETHER Trial research consortium. This consortium was established with funding support from FastGrants, the Bill & Melinda Gates Foundation and the Rainwater Charitable Foundation, and is led by Dr. Edward Mills and Dr. Gilmar Reis.
“Like other researchers, we have noticed a significant prevalence of GI symptoms in the thousands of Covid-19 patient volunteers that have proceeded through the TOGETHER umbrella clinical trial to date”, said Dr. Mills “These symptoms are severe in some patients, and so we are excited to have this shot at making a difference in the patients’ lives with LMN-301.”
The Phase 2 clinical trial is expected to commence enrollment in late winter following clearance by regulators and research ethics committees.
About GI Infection and Covid-19
The “respiratory” virus that causes Covid-19 also infects the GI tract. In one widely cited study,[i] a majority of Covid-19 patients presented with both GI and respiratory symptoms, and 25% had only GI symptoms. These symptoms can be both severe and wide-ranging[ii], in some cases requiring surgical resection[iii]. GI infection by the virus is also thought to contribute to liver damage[iv] and acute respiratory distress syndrome (ARDS)[v], both common long-term symptoms of severe Covid-19. This is not surprising: 25% of MERS[vi] cases and 16-73% of SARS[vii] cases in the 2002-2003 outbreak also presented with significant GI symptoms, and it is widely accepted that the original 2003 SARS virus transmitted efficiently through the fecal-oral route[viii], a phenomenon that could also explain recurring Covid-19 superclusters. Indeed, though researchers’ ability to definitively nail down the source of any particular case of transmission to a particular transmission route, several groups have published studies documenting transmission under circumstances that strongly implicate GI transmission.[ix],[x],[xi] Lumen’s GI-targeted therapy may therefore not only reduce overall viral burden, inhibit disease progression, and accelerate recovery, but also prevent a potentially significant source of Covid-19 transmission.
The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. The Lumen program was funded under MTEC solicitation MTEC-20-09-COVID-19_Treatment_MIDRP and is funded by the USAMRDC. For more information, visit: www.mtec-sc.org.
[i] Han, Chaoqun, et al. “Digestive symptoms in COVID-19 patients with mild disease severity: clinical presentation, stool viral RNA testing, and outcomes.” The American journal of gastroenterology (2020).
[ii] Lin, Lu, et al. “Gastrointestinal symptoms of 95 cases with SARS-CoV-2 infection.” Gut (2020).
[iii] Bhayana, Rajesh, et al. “Abdominal imaging findings in COVID-19: preliminary observations.” Radiology (2020).
[iv] Chai, Xiaoqiang, et al. “Specific ACE2 expression in cholangiocytes may cause liver damage after 2019-nCoV infection.” biorxiv (2020).
[v] Gul, Fahad, et al. “Meta-analysis of outcomes of patients with COVID-19 infection with versus without gastrointestinal symptoms.” Baylor University Medical Center Proceedings. Taylor & Francis, 2020.
[vi] Assiri, Abdullah, et al. “Epidemiological, demographic, and clinical characteristics of 47 cases of Middle East respiratory syndrome coronavirus disease from Saudi Arabia: a descriptive study.” The Lancet infectious diseases 13.9 (2013).
[vii] World Health Organization. Consensus document on the epidemiology of severe acute respiratory syndrome (SARS). No. WHO/CDS/CSR/GAR/2003.11. World Health Organization, 2003.
[viii] Gormley, Michael, et al. “Pathogen cross-transmission via building sanitary plumbing systems in a full scale pilot test-rig.” PloS one 12.2 (2017).
[ix] Kang, Min, et al. “Probable evidence of fecal aerosol transmission of SARS-CoV-2 in a high-rise building.“ Annals of internal medicine 173.12 (2020): 974-980.
[x] Yuan, Jun, et al. “Sewage as a possible transmission vehicle during a coronavirus disease 2019 outbreak in a densely populated community: Guangzhou, China, April 2020.“ Clinical Infectious Diseases (2020).
[xi] Al Mayahi, Zayid K., et al. “Non-Respiratory Droplet Transmission of COVID-19 in the Isolation Ward of a Secondary Hospital in Oman: A Return to Isolation Basics.“ Infectious Diseases in Clinical Practice (2021).